### 📈 Drug Quality & Regulatory Compliance in Sri Lanka

The National Medicines Regulatory Authority (NMRA) faces a significant "implementation gap" between its legal mandate and the practical enforcement of quality standards for the private sector, which accounts for 60% of the total spend on drugs and medical supplies. • Regulatory Framework & Gaps Private Sector imports exceed 4,000 items, compared to under 1,000 in the State Pharmaceuticals Corporation (SPC) system. While the NMRA Act No. 5 of 2015 mandates ensuring "efficacious, safe, and good quality medicines," audits reveal a massive registration backlog and a "reactive" rather than "proactive" testing culture. The National Medicines Quality Assurance Laboratory (NMQAL) lacks the resources to test the volume of private imports, leading to reliance on "provisional" registrations. • Audit & Oversight Findings Emergency Waivers: During the 2022–2023 crisis, Section 109 was overused to bypass essential quality checks. Data Integrity: A 2023–2025 COPE investigation highlighted a "data deletion incident" that lost critical digital records of importers and quality certificates. Staffing: The NMRA operates with a technical staff smaller than a single large private hospital, hindering market surveillance. • Strategic Reforms (2025–2026) Digital Integration: A World Bank-funded "Digital Gatekeeper" project aims to link NMRA with Customs to automate batch certificate verification. Regulatory Shifts: New mandatory labeling (stickers) and digital data collection for all imports since January 2023 are being implemented to curb falsified products. Proposed "Positive List": International bodies suggest a "Private Sector Essential Medicines List" to prioritize surveillance on therapeutically necessary brands, though this faces potential industry pushback. _Note: Summary based on provisional audit reports and current situational analyses._ ---